Process characterization (PC) and process validation (PV) are integral components of pharmaceutical R&D, and are essential prerequisites for product registration to obtain marketing authorization. The pharmaceutical manufacturing process is continuously monitored and controlled to ensure the consistent production of products that meet quality requirements.

Process Characterization Development Workflow

Adhering to the QbD concept

- Based on the internationally accepted QbD concept and rigorous DoE methodology, process verification and continuous lifecycle management are implemented. The project design is conducted in strict accordance with the regulatory requirements (NMPA/FDA/EMA) of the target marketing application region.

- Customized solutions can be offered based on the specific needs of clients and the particular stage of the project, ensuring flexible scheduling, multi-line parallelization, and shortened project timelines.

- A robust process and production team has accumulated extensive experience in PC/PV projects.